BEUDAMED
    FDA Adverse Event Death Summary report: N

    ETHICON LIGACLIP MULTIPLE CLIP APPLIER

    MDR report key: 13087254 · Received December 27, 2021

    Report

    Report Number
    MW5106257
    Event Type
    Death
    Date Received
    December 27, 2021
    Date of Event
    October 17, 2021
    Report Date
    December 22, 2021
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT WAS A (B)(6) FEMALE WITH A PAST MEDICAL HISTORY OF THYROID MASS WHO UNDERWENT A HEMI-THYROIDECTOMY. DURING THE PROCEDURE A TOTAL OF 5 LIGATING CLIPS WERE PLACED ON THE SUPERIOR THYROID ARTERY (1 MEDIUM CLIP AND 2 SMALL CLIPS ON ONE SIDE THAT INTENTIONALLY REMAINED IN THE WOUND, AND 2 CLIPS ON ONE SIDE THAT WERE INTENTIONALLY REMOVED). ALL OTHER VESSELS WERE DOUBLE CLIPPED WITH NO EXTRA BLEEDING NOTED FOLLOWING INDUCED VALSALVA MANEUVERS. BEFORE SURGICAL CLOSURE, THE INCISION WAS IRRIGATED, DRIED WITH A SPONGE, AND NOTED TO BE DRY. THE INCISION WAS CLOSED AND THE PATIENT WAS MOVED TO RECOVERY. SHE WAS DISCHARGED HOME THE SAME DAY FOLLOWING AN APPROPRIATE RECOVERY. SEVERAL HOURS LATER, WHILE HOME, SHE EXPERIENCED RAPID NECK SWELLING AND SHORTNESS OF BREATH. DURING TRANSPORT BY EMS, THE PATIENT EXPERIENCED CARDIAC ARREST. THE PATIENT WAS RETURNED TO THE OPERATING FACILITY. SHE WAS EMERGENTLY TAKEN TO THE OPERATING ROOM FOR NECK EXPLORATION. THE MAIN BLEEDING SOURCE WAS FOUND TO BE THE SUPERIOR THYROID ARTERY. SHE REMAINED IN CRITICAL CONDITION FOLLOWING THIS PROCEDURE AND CARE WAS WITHDRAWN ON (B)(6) 2021. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1987050 ETHICON LIGACLIP MULTIPLE CLIP APPLIER APPLIER, SURGICAL, CLIP GDO ETHICON ENDO-SURGERY, LLC MCS20
    1987051 ETHICON LIGACLIP MULTIPLE CLIP APPLIER APPLIER, SURGICAL, CLIP GDO ETHICON ENDO-SURGERY, LLC
    1987052 ETHICON LIGACLIP MULTIPLE CLIP APPLIER APPLIER, SURGICAL, CLIP GDO ETHICON ENDO-SURGERY, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Death